As you may know, a project of restriction of Cyclopentasiloxane (D5) and Cyclotetrasiloxane (D4) was initiated in 2015 and aims to limit at 0.1% the use of these two ingredients in wash-off1 cosmetic products. These limitations are not related to the EU Cosmetics Regulation (addressing consumer safety issues) but respond to environmental concerns within the scope of the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation (EC No 1907/2006).2
On February 20, 2017, the World Trade Organization (WTO) was notified of this regulatory proposal3 and the public consultation. Notifying the WTO is usually the very last step of a regulatory development and projects of legislation rarely get stopped at this stage. The amendment of Annex XVII4 to the REACH Regulation will probably be published in September 2017.
Then a transition period of two years will start, meaning that all wash-off cosmetic products on the EU market will have to contain less than 0.1% of D5 and less than 0.1% of D4 by September 2019. This change is expected to have a significant impact on the cosmetic industry and BIORIUS estimated that this project restriction should impact about 5% of the wash-off products currently placed on the EU Market.
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Formulators should also be informed that the European Chemical Agency (ECHA), which is responsible for maintaining the REACH Regulation, will submit a new project of restriction on April 13, 2018. Still related to environmental concerns, this regulatory development aims to restrict the use of D4 and D5 at concentrations below 0.1% but, this time, in leave-on cosmetic products5.
Without surprise, the impact of such a restriction is expected to be very important. Although the project is still in the upstream phase, its implementation seems relatively certain given the political nature of this dossier. Indeed, it has been shown that both the European Commission and the European Council6 are strongly committed to phase out these ingredients in the short term.
Finally, it is noteworthy that the outlined above developments only impacts D5 in practice. In effect, the use of D4 in cosmetic products will be prohibited well before the implementation of the amendment to the REACH Regulation. You may remember that D4 has been officially classified Reprotoxic 2 (see Annex VI of Regulation EC No 1272/2008) and, pursuant to Article 15 of the EU Cosmetics Regulation (EC No 1223/2009), cannot be used in cosmetics any longer. The amendment of the EU Cosmetics Regulation7 has been voted and should be officially published by February 2018. Attention should be paid to the fact that no transition periods will be granted to implement this ban of D4.
For these reasons, I recommend that D4 and D5 be phased out of cosmetic products and replaced by less problematic ingredients. Silicone and silicone-free alternatives exist and can suitably replace D4 and D5 although the reformulation requires some efforts. The second article of the series “Preservative Deep Dive: Parabens and their Alternatives” will be published in the coming weeks and proposes some options in this regard.
- The EU Cosmetics Regulation uses the term “rinse-off” for products that are washed off, but including wipe-off products such as baby wipes. As wipe-off products do not normally lead to aquatic emissions, it was not considered appropriate to include them within the restriction and therefore the term “wash-off” has been used.
- Regulation (EC) No 1907/2006 - REACH
- Regulatory proposal (G/TBT/N/EU/456) and its annex
- Substances restricted under REACH (Annex XVII to REACH)
- Current Restriction intention
- Proposal for a Council Decision on the submission, on behalf of the European Union, of a proposal for the listing of additional chemicals in Annex A, B and/or C to the Stockholm Convention on Persistent Organic Pollutants
- Regulatory proposal (G/TBT/N/EU/489) and its annex
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